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Isavuconazole: A Review in Invasive Aspergillosis and Mucormycosis

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Abstract

Isavuconazole is a second-generation triazole with activity against a broad spectrum of clinically important fungi. Its water-soluble prodrug, isavuconazonium sulfate (Cresemba®), available in interchangeable intravenous and oral formulations, is approved in the USA and EU for the treatment of adults with invasive aspergillosis and mucormycosis. In international phase III clinical trials, isavuconazole was efficacious and generally well tolerated in the treatment of these life-threatening diseases. In the phase III SECURE trial, isavuconazole was non-inferior to voriconazole for the primary treatment of invasive mould disease (primarily aspergillosis) and was associated with fewer drug-related treatment-emergent adverse events (TEAEs) than voriconazole. In addition, the single-arm, phase III VITAL trial and a matched case–control analysis of isavuconazole- versus amphotericin B-treated patients provided evidence of the efficacy of isavuconazole in the treatment of mucormycosis. The most commonly reported TEAEs among isavuconazole recipients were gastrointestinal disorders such as nausea, vomiting and diarrhoea. Isavuconazole has several other attributes that make it a useful new treatment option for these invasive mould diseases, including predictable pharmacokinetics, excellent bioavailability, no food effect with the oral formulation, and its potential utility in renally impaired patients given the absence of cyclodextrin in the intravenous formulation.

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Acknowledgments

During the peer review process, the manufacturer of isavuconazonium sulfate was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Matt Shirley & Lesley J. Scott

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  1. Matt Shirley
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Correspondence to Matt Shirley.

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The preparation of this review was not supported by any external funding.

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Matt Shirley and Lesley Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: W. Heinz, University of Würzburg Medical Center, Department of Internal Medicine II, Würzburg, Germany; M. Hönigl, Department of Internal Medicine, Medical University of Graz, Graz, Austria; F. Lamoth, Service of Infectious Diseases, Department of Medicine, and Institute of Microbiology, Lausanne University Hospital, Lausanne, Switzerland; G. Maschmeyer, Department of Haematology, Oncology and Palliative Care, Klinikum Ernst von Bergmann, Potsdam, Germany.

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Shirley, M., Scott, L.J. Isavuconazole: A Review in Invasive Aspergillosis and Mucormycosis. Drugs 76, 1647–1657 (2016). https://doi.org/10.1007/s40265-016-0652-6

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